Approximately 6 million Americans are affected by heart failure, which occurs when the heart is too weak to effectively pump and circulate blood throughout the body. Any number of conditions, such as weakened heart muscle and damaged vessels, can lead to heart failure. Prescription drugs may help manage some symptoms but do not always succeed at relieving all symptoms or preventing heart failure deterioration.

Specifically, the clinical trial will study a novel device known as CardioFit®, which involves implanting a pacemaker-sized stimulator under the skin of the chest to help stimulate the vagus nerve on the right side of the neck. The large vagus nerve runs from the brain stem down to the abdomen and is responsible for regulating multiple bodily functions, including heart rate. A lead from the device to the vagus nerve delivers mild electrical pulses in an effort to reduce heart rate, stress, and workload on the cardiac muscle and ultimately improve overall heart function.

“Vagus nerve stimulation may be the therapy we have long been waiting for to bring relief to heart failure patients with chronic symptoms and protect them, as well, from dangerous and potentially fatal arrhythmias,” says Vivek Reddy, MD, Director of Arrhythmia Services at The Mount Sinai Hospital, who is leading the research. “I am excited to be working with our heart failure and neurosurgery colleagues to offer this potentially transformative therapy to our patients.”

The study will compare the benefits of vagus nerve stimulation, in combination with medications, to the standard therapy of medication. “We will also investigate vagus nerve stimulation therapy’s ability to reduce hospitalization, a major issue for heart failure patients, as well as its capability to reduce mortality in this high-risk population,” says Ajith P. Nair, MD, Director of the Pulmonary Hypertension Program in the Advanced Heart Failure and Transplantation Program at Mount Sinai Heart.

A key member of the team is Brian H. Kopell, MD, Director of the Center for Neuromodulation. “At Mount Sinai, we have successfully used vagus nerve stimulation for refractory epilepsy in patients with uncontrollable seizures, and to treat patients with major depression, who do not have good responses to medication therapy,” says Dr. Kopell. “We now want to see what clinical benefits are possible for heart failure.”

The clinical trial, known as INOVATE-HF (Increase of Vagal Tone in Chronic Heart Failure) is enrolling up to 650 patients in the United States and Europe.